FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73729–73752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · MQB
Canon, Inc.
Radiology · 15d
Cleared Oct 03, 2002
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES
K020334 · GEI
Jac-Cell Medic Corporation
General & Plastic Surgery · 245d
Cleared Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · DAP
bioMerieux, Inc.
Hematology · 204d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · DQK
Radi Medical Systems AB
Cardiovascular · 90d
Cleared Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · HNO
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · HWC
Arthrex, Inc.
Orthopedic · 84d
Cleared Oct 03, 2002
AURORA SR
K022266 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 83d
Cleared Oct 03, 2002
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT...
K022300 · ELM
Dental Vipi Ltda
Dental · 79d
Cleared Oct 03, 2002
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE...
K022475 · GEI
Arthrocare Corp.
General & Plastic Surgery · 66d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · MHX
Datex-Ohmeda
Cardiovascular · 66d
Cleared Oct 03, 2002
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN...
K022808 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 41d
Cleared Oct 03, 2002
CSV12 SOFTWARE VIEWER
K022896 · LLZ
Acuson Corp.
Radiology · 30d
Cleared Oct 03, 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION...
K022904 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 30d
Cleared Oct 03, 2002
QSC-63-INT SHOULDER ARRAY COIL SET
K022910 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Oct 03, 2002
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND...
K022939 · DTE
Osypka Medical, Inc.
Cardiovascular · 29d
Cleared Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 20d
Cleared Oct 02, 2002
BIOVER
K011208 · DXC
Biover AG
Cardiovascular · 531d
Cleared Oct 02, 2002
ENDIUS ATAVI SYSTEM
K022199 · HRX
Endius, Inc.
Orthopedic · 89d
Cleared Oct 02, 2002
CLEAN 'N' OIL
K022264 · EGS
Svenska Dental Instruments AB
Dental · 82d
Cleared Oct 02, 2002
LIGHT TIP
K022265 · EBZ
Svenska Dental Instruments AB
Dental · 82d
Cleared Oct 02, 2002
TOKUYAMA REBASE II
K022641 · EBI
Tokuyama America, Inc.
Dental · 55d
Cleared Oct 02, 2002
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER...
K022867 · JJY
Cliniqa Corporation
Chemistry · 35d
Cleared Oct 02, 2002
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE
K022885 · JJY
Cliniqa Corporation
Chemistry · 33d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d